COMMENT CSJ THE CLINICAL SERVICES JOURNAL Editor


Chris Shaw chrisshaw@stepcomms.com


Technical Editor Kate Woodhead


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THE CLINICAL SERVICES JOURNAL is published in January, February, March, April, May, June, August, September, October and November by Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR, UK.


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Too late for transition?


With the possibility of a no-deal Brexit edging ever nearer, industry is becoming increasingly anxious about the timetable for the EU Medical Device Regulation. The US has raised serious concerns about the EU’s Medical Device and In Vitro Diagnostic regulations (MDR/IVDR) and called on the EU to delay implementation by three years. In a statement to the World Trade Organisation Committee, the US has urged the EU to delay MDR/IVDR implementation to “allow for US exporters to adapt to the new requirements.” The US statement further argues that the MDR/IVDR provisions intended to provide industry with transitional relief, which include the legislation's provisions for warehousing and the grace periods, have been “insufficient.”


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An EU statement from 18 July, however, tells the WTO's committee that, “there are no grounds for the time being to explore any amendment to the transitional periods.” On the current status of Notified Bodies’ (NB) designation, the EU states that the final number of newly designated notified bodies (NBs) will be “slightly lower compared to the current situation" and that "it could take some time for many” NBs to submit their applications based on their preparedness level because, “one of the declared objectives of the new regulation is to have in place a safer” NB infrastructure. The European Commission (EC) has designated only two NBs – BSI UK and TÜV SÜD – against MDR so far, and none against IVDR. It has also set forth only two of the MDR/IVDR implementing acts – just one of which has been adopted so far. The EC adopted the implementing act on the list of codes for designating NBs under MDR/IVDR in November 2017 and, in July 2019, it issued the draft implementing acts on the common specifications for the reprocessing of single-use medical devices in accordance with MDR. According to Peter Rose, managing director Europe at life sciences consultancy Maetrics, there are issues with the EU Medical Device Regulation timeable. “Just two notified bodies are designated,” he said, “and one of them – BSI UK – will be pointless if we have a hard Brexit (which is looking increasingly likely by the day). “Three year transitions periods are well


SEPTEMBER 2019


established in our industry, but never have I seen a transition period being used to get the system ready.” The EU has asserted that it is,


“committed to take steps to encourage” NBs to use audit reports from the Medical Device Single Audit Program, “in a manner that is compatible with EU legislative requirements.” It has announced that it expects finalising its work on guidelines for such purposes, which is reportedly already underway, by the end of 2019.


Up-classified Class I medical devices cannot even benefit from the extended transition period afforded to higher classes


However, Peter Rose contends that industry and NBs need three years from when the system is ready. He asserted: “From when there are enough NBs, when all the Implementing Acts have been issued and ratified, from when all the Standards are harmonised, from when the Common Specifications are written and published, and from when the European Database on Medical Devices (EUDAMED) is fully functional.”


While it is widely accepted that a NB will take between six to nine months to certify a device, Peter believes that it’s not looking possible without all of the above. “Up-classified Class I medical devices cannot even benefit from the extended transition period afforded to higher classes,” he concluded. “They must be compliant by the date of application (26 May 2020); and this is looking very difficult to achieve.”


Chris ShawlEditor chrisshaw@stepcomms.com


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